Acupuncture as an Adjunctive Treatment for Hepatitis C Patients
试验速览
- 阶段
- 不适用
- 发起方
- 试验地点
- 2
研究概览
简要总结
Objective: to study the effect of Acupuncture on liver cirrhosis, SVR and health related quality of life in HCV patients receiving standard treatment (Peg Interferon+ Ribavirin).
Methods: 60 HCV patients receiving standard treatment (Peg Interferon+ Ribavirin) will undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) to achieve baseline characteristics(17,18,19). Patients will be randomized into intervention and control groups, 30 patients each.In the Intervention group each patient will receive an acupuncture treatment once a week for 12 consecutive weeks(Max 12, Min 8 treatments). Treatment protocol will be individualized for each patient according to TCM diagnosis. This treatment protocol is acceptable and has been published(20,21,22).In the control group patients will receive standard treatment alone, with no other intervention.
Data collection: after 12 weeks patients will again undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) in order to detect changes from baseline and group differences.
Inclusion criteria: adult patients with a confirmed HCV infection
Exclusion criteria:
Under 18 years Can not receive standard Peg interferon+ ribavirin treatment for any reason Psychiatric diagnosis Anaemia of hematologic origin Diabetic patient with uncontrolled diabetes Congestive heart failure, arrhythmia Hepatocellular carcinoma HIV infection Hepatitis B infection Auto immune liver disease or alcoholic liver disease Study duration: 1 year Study Location: "Ziv" medical center, division of liver disease, Israel
详细描述
Background:
Hepatitis C is an infectious disease affecting primarily the liver, caused by the hepatitis C virus (HCV). HCV is a worldwide problem, An estimated 130-170 million people worldwide are infected with HCV, in Israel there are an estimated 80,000 patients. Most patients infected with HCV have chronic liver disease, which can progress to cirrhosis and Hepatocellular carcinoma (HCC). Chronic infection with HCV is one of the most important causes of chronic liver disease and the most common indication for orthotropic liver transplantation (OLT) in the United States. Medical care costs associated with the treatment of HCV infection in the United States are estimated to be more than $600 million a year.
Chronic hepatitis C infection and chronic active hepatitis are slowly progressive diseases and result in severe morbidity in 20-30% of infected persons. Although acute HCV infection is usually mild, chronic hepatitis results in at least 75% of patients. Cirrhosis develops in 20-50% of patients with chronic hepatitis C infection. Liver failure and Hepatocellular carcinoma can eventually result. Hepatocellular carcinoma occurs in 11-19% of patients . The diagnosis of acute or chronic HCV infection generally requires testing of serum for both antibody to HCV (anti-HCV) and for HCV RNA. The recombinant immunoblot assay is used to confirm HCV infection. A sensitive quantitative HCV RNA assay is recommended for diagnosis because it also provides information on the level of virus which is helpful in management of the disease.
Combination therapy with pegylated interferon Alfa (PEG-IFN Alfa) and the nucleoside analogue ribavirin is the current standard of care in patients infected with HCV. Treatment of chronic HCV infection has 2 goals. The first is to achieve sustained eradication of HCV (ie, sustained virologic response [SVR]), which is defined as the persistent absence of HCV RNA in serum 6 months or more after completing antiviral treatment. The second goal is to prevent progression to cirrhosis, Hepatocellular carcinoma (HCC), and decompensated liver disease requiring liver transplantation.
Adverse effects are common with IFN and ribavirin combination therapy. Approximately 75% of patients experience one or more of adverse effects. Common adverse effects are :
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a confirmed HCV infection
排除标准
- •Under 18 years
- •Can not receive standard Peg interferon+ ribavirin treatment for any reason
- •Psychiatric diagnosis
- •Anaemia of hematologic origin
- •Diabetic patient with uncontrolled diabetes
- •Congestive heart failure, arrhythmia
- •Hepatocellular carcinoma
- •HIV infection
- •Hepatitis B infection
- •Auto immune liver disease or alcoholic liver disease
研究者
Assy Nimer
Prof. Assy Nimer
Ziv Hospital